NCT05863429

Observational National Vaccine Study

Observational Study to Evaluate the Effectiveness, Immunogenicity and Safety of Inactivated COVID-19 Vaccine (TURKOVAC) Application

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Health Institutes of Turkey · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To assess the long-term safety of TURKOVAC in individuals who have not previously received the COVID-19 vaccine or who have received their primary vaccination with inactivated or mRNA vaccine, or who have received their primary vaccination with similarly inactivated or mRNA vaccine and who subsequently received the first dose or second dose of booster vaccine, who meet the inclusion/exclusion criteria of the study.

Detailed description

The primary objective of the study was to evaluate the long-term safety of TURKOVAC in individuals who had never received a COVID-19 vaccine before, or who received their primary vaccination with inactivated or mRNA vaccine, or who received their primary vaccination with similarly inactivated or mRNA vaccine, and who subsequently received a first dose or second dose of booster vaccine, in individuals who met the inclusion/exclusion criteria of the study. The secondary objective of the study was to evaluate the immunogenicity of TURKOVAC in individuals who meet the inclusion/exclusion criteria of the study.

Conditions

• COVID-19 Infection

Interventions

Type	Name	Description
BIOLOGICAL	Taking biological samples (blood) and keeping records with phone calls	Within the scope of the study, no intervention will be made to the participants. According to the vaccination program implemented in Turkey, subjects who apply to the study centers for TURKOVAC vaccine will be invited to the study.

Timeline

• Start date: 2022-05-18
• Primary completion: 2023-11-01
• Completion: 2024-04-01
• First posted: 2023-05-18
• Last updated: 2024-05-24

Locations

8 sites across 1 country: Turkey (Türkiye)